MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC. REVANESSE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

The clinical complaint is in the process of investigation.The lot number has not been verified due to the absence of information.It will be confirmed whether any clinical complaints have been found for the particular lot number in question once requested information is provided.The batch record, qc test reports, and training of staff will be analysed and be determined that product is within required specifications, and manufactured according to appropriate procedures once lot is verified.Prollenium medical technologies' medical director's response to this adverse event will be provided to the clinic along with the letter indicating approved areas for injection for revanesse versa+ and revanesse lips+ products when requested information for conducting investigation is provided.

Event Description

Based on the information provided, the patient got injected with revanesse dermal fillers in the lips area of the patient on (b)(6) 2022.The lot of the product injected was not provided and, therefore, not verified.Amount of product injected was not specified.Patient is a female; date of birth not provided.According to the initial communication, the patient has called and come back in for evaluation on a couple occasions since initial procedure because the patient was having pain/discomfort still at the injection site.Patient was seen (b)(6) 2022 and had another appointment on (b)(6) 2022 with the clinic for a dissolving procedure.In addition, the patient was not pleased with some pulling she is having which is noticeable especially when she smiles.No information regarding topic anaesthetic has been provided.No information regarding allergies has been provided.No information regarding medical history and presence of risk factors have been provided.On 07 feb 2022, same day of notification, qa department at prollenium medical technologies contacted clinic/injector requesting information regarding this clinical complaint, no response from the injector/clinic has been received.On 14 feb 2022, as a result of no response, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint, no response from the injector/clinic has been received.On 03 mar 2022, as a result of no response, qa department at prollenium medical technologies contacted clinic/injector again requesting information regarding this clinical complaint, no response from the injector/clinic has been received.On 07 mar 2022, a sales representative informed the qa department at prollenium medical technologies that she will follow-up with the clinic regarding this adverse event again.The qa department at prollenium medical technologies will continue the investigation.

Event Description

Internal report number: (b)(4).

• Brand Name: REVANESSE
• Type of Device: REVANESSE
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC.; 138 industrial parkway n; aurora, on L4G 4 C3; CA L4G 4C3
• Manufacturer Contact: ario khoshbin ; 138 industrial parkway n; aurora, on L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 13693827
• MDR Text Key: 287007555
• Report Number: 3004423487-2022-00008
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P160042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female